为人工智能和数字健康发展制定安全、符合法规的生活实验室路线图

IF 11.7 1区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

Science Advances Pub Date : 2025-05-14 DOI:10.1126/sciadv.adv7719

Stephen Gilbert, Rebecca Mathias, Anett Schönfelder, Magdalena Wekenborg, Julia Steinigen-Fuchs, Anja Dillenseger, Tjalf Ziemssen

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引用次数: 0

摘要

安全和灵活的实验空间对于开发支持人工智能的医疗设备和数字健康创新至关重要。“生活实验室”为在接近真实世界的环境中测试技术提供了一个协作环境，捕捉用户的观点和结果，这在传统测试中经常被忽略。然而，Living Labs的灵活性经常与欧盟严格的医疗设备监管框架相冲突，这些医疗设备不是为数字技术设计的。我们研究了这个交叉点，展示了评估和患者互动的灵活性如何与安全护栏共存。我们的方法集成了技术准备、先发制人的规划和迭代修改，以弥合创新和监管，促进适应性医疗保健技术的发展。

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A roadmap for safe, regulation-compliant Living Labs for AI and digital health development

Safe and agile experimentation spaces are essential for developing AI-enabled medical devices and digital health innovations. “Living Labs” offer a collaborative environment for testing technologies in near-real-world settings, capturing user perspectives and outcomes, often missed in traditional testing. However, the flexibility of Living Labs often clashes with the European Union’s rigid regulatory frameworks for medical devices that were not designed for digital technologies. We examine this intersection, showing how flexibility in evaluation and patient interaction can coexist with safety guardrails. Our approach integrates technology readiness, preemptive planning, and iterative modifications to bridge innovation and regulation, fostering adaptive health care technology development.

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来源期刊

Science Advances 综合性期刊-综合性期刊

CiteScore

21.40

自引率

1.50%

发文量

1937

审稿时长

29 weeks

期刊介绍： Science Advances, an open-access journal by AAAS, publishes impactful research in diverse scientific areas. It aims for fair, fast, and expert peer review, providing freely accessible research to readers. Led by distinguished scientists, the journal supports AAAS's mission by extending Science magazine's capacity to identify and promote significant advances. Evolving digital publishing technologies play a crucial role in advancing AAAS's global mission for science communication and benefitting humankind.